Sexually Transmitted DiseasesPhase 2/3NCT00164619
Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR
A Phase 2/3 study testing VOICES/VOCES and Standard STD clinic services in people with Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 2 sites in 2 countries.
Trial summary
The purpose of the project is to determine whether the VOICES/VOCES intervention, that was shown to be effective in a research study, is still effective when delivered by STD/HIV prevention agencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- VOICES/VOCES and Standard STD clinic services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,660 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2001to Mar 2008
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STD infection at time of recruitment
- Accept treatment for STD infection at time of recruitment
Who cannot join
- Age under 18 years
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Puerto Rico1 site
Centro Latino Americano de Enfermedades de Transmission Sexual
San Juan, 00922
About this study
Official title: Testing the Effectiveness of the VOICES/VOCES Intervention Package as Implemented by STD and HIV Prevention Agencies That Target Hispanics and African Americans in the U.S. and Puerto Rico
The purpose of the project is to determine whether the VOICES/VOCES intervention, that was shown to be effective in a research study, is still effective when delivered by STD/HIV prevention agencies.
VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult men and women at high risk for STD/HIV. It encourages condom use and improves condom negotiation skills. A health educator delivers the intervention to groups of 4 to 8 clinic patients in a private room. Groups are made up of people of the same sex and same race or ethnicity. Information on STD/HIV risk behaviors and condom use is delivered by culturally-specific videos, group discussion, and a poster presenting features of various condom brands. Participants role-play condom negotiation modeled in the videos. At the end of the session they are given sample condoms of their choice.
In this project, health educators from the health departments of New York City and San Juan, Puerto Rico conducted the VOICES/VOCES intervention with a sample of patients from one STD clinic in each of their cities. Researchers helped the health departments test whether the intervention is effective when local health educators deliver it.
Read the detailed description
This project was an RCT with 1699 patients assigned to receive the VOICES/VOCES intervention and 1707 to receive standard of care at each of the two STD clinics (total N=3406). Participant outcomes and their measures are:
- Change in knowledge and attitudes about condoms as determined by participant profile and survey data
- Condom acquisition as determined by project coupon redemption data
- STD incidence as determined by medical chart review and/or surveillance data
In addition, cost accounting data on the amounts and types of resources required to implement the intervention were used to evaluate the intervention's cost-effectiveness. Process evaluation data allow identification of factors that influenced intervention implementation and the effectiveness of the intervention.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- VOICES/VOCES, Standard STD clinic services
- Keywords
- controlled clinical trial, behavioral intervention, prevention 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.
VOICES/VOCESBehavioural
Also called No other names
45-minute intervention for small groups of African American and Hispanic heterosexual men and women. Group members are same gender and race/ethnicity. View culturally-specific condom promotion video. Facilitated group discussion to build skills in condom use and condom negotiation. Education on condom varieties to overcome participants' personal barriers to condoms use. Distribution of 3 specialty condoms of participant's choice (i.e., different sizes, textures, thicknesses, lubrication, material). [see Brief Summary above]
Standard STD clinic servicesBiological
Also called No other names
Individual physical exam, STD/HIV tests, treatment as indicated
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard STD clinic services and the VOICES/VOCES intervention Receives: Behavioral: VOICES/VOCES |
| 2 | Active comparator | Standard STD clinic services Receives: Biological: Standard STD clinic services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat STD infection
Measured: Average of 15-months post-intervention
Secondary outcomes (2)
Change in knowledge and attitudes
Measured: Immediately post-intervention
Condom coupon redemption
Measured: 3-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 posted14 Sep 2005 (estimated)
- Study startJul 2001
- Primary completionNov 2006
- Study completionMar 2008
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 Sexually Transmitted DiseasesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Lydia O'Donnell, Ed.D., Principal investigator, Education Development Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164619
- Sponsor's protocol ID
- CDC-NCHSTP-4048
- Other IDs
- Contract 200-2001-00132
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Donnell CR, O'Donnell L, San Doval A, Duran R, Labes K. Reductions in STD infections subsequent to an STD clinic visit. Using video-based patient education to supplement provider interactions. Sex Transm Dis. 1998 Mar;25(3):161-8. doi: 10.1097/00007435-199803000-00010.
PubMed 9524995
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of the VOICES/VOCES Intervention Package as Implemented by STD and HIV Prevention Agencies That Target Hispanics and African Americans in the U.S. and Puerto Rico
- ClinicalTrials.gov ID
- NCT00164619
- Acronym / sponsor ID
- CDC-NCHSTP-4048
- Conditions
- Sexually Transmitted Diseases
- Keywords
- controlled clinical trial, behavioral intervention, prevention intervention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,660 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jul 2001
- Primary completion
- Nov 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Sep 2005 (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 purpose of the project is to determine whether the VOICES/VOCES intervention, that was shown to be effective in a research study, is still effective when delivered by STD/HIV prevention agencies.
VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult men and women at high risk for STD/HIV. It encourages condom use and improves condom negotiation skills. A health educator delivers the intervention to groups of 4 to 8 clinic patients in a private room. Groups are made up of people of the same sex and same race or ethnicity. Information on STD/HIV risk behaviors and condom use is delivered by culturally-specific videos, group discussion, and a poster presenting features of various condom brands. Participants role-play condom negotiation modeled in the videos. At the end of the session they are given sample condoms of their choice.
In this project, health educators from the health departments of New York City and San Juan, Puerto Rico conducted the VOICES/VOCES intervention with a sample of patients from one STD clinic in each of their cities. Researchers helped the health departments test whether the intervention is effective when local health educators deliver it.
Detailed description
This project was an RCT with 1699 patients assigned to receive the VOICES/VOCES intervention and 1707 to receive standard of care at each of the two STD clinics (total N=3406). Participant outcomes and their measures are:
- Change in knowledge and attitudes about condoms as determined by participant profile and survey data
- Condom acquisition as determined by project coupon redemption data
- STD incidence as determined by medical chart review and/or surveillance data
In addition, cost accounting data on the amounts and types of resources required to implement the intervention were used to evaluate the intervention's cost-effectiveness. Process evaluation data allow identification of factors that influenced intervention implementation and the effectiveness of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: VOICES/VOCESStandard STD clinic services and the VOICES/VOCES intervention |
| 2 | Active comparator | Biological: Standard STD clinic servicesStandard STD clinic services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- STD infection at time of recruitment
- Accept treatment for STD infection at time of recruitment
Key exclusion criteria (1 listed)
- Age under 18 years
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 |
|---|---|---|
| VOICES/VOCESAlso: No other names45-minute intervention for small groups of African American and Hispanic heterosexual men and women. Group members are same gender and race/ethnicity. View culturally-specific condom promotion video. Facilitated group discussion to build skills in condom use and condom negotiation. Education on condom varieties to overcome participants' personal barriers to condoms use. Distribution of 3 specialty condoms of participant's choice (i.e., different sizes, textures, thicknesses, lubrication, material). [see Brief Summary above] | Behavioural | 1 |
| Standard STD clinic servicesAlso: No other namesIndividual physical exam, STD/HIV tests, treatment as indicated | Biological | 2 |
Primary outcome
Repeat STD infection
Time frame: Average of 15-months post-intervention
2 secondary outcomes
Change in knowledge and attitudes
Time frame: Immediately post-intervention
Condom coupon redemption
Time frame: 3-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 5 Jun 2008.
- Background: PubMed 9524995O'Donnell CR, O'Donnell L, San Doval A, Duran R, Labes K. Reductions in STD infections subsequent to an STD clinic visit. Using video-based patient education to supplement provider interactions. Sex Transm Dis. 1998 Mar;25(3):161-8. doi: 10.1097/00007435-199803000-00010.
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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.
Lydia O'Donnell, Ed.D. principal investigator
Education Development Center, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VOICES/VOCES and Standard STD clinic services in people with Sexually Transmitted Diseases, run by Centers for Disease Control and Prevention at 2 sites in 2 countries.
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 5 Jun 2008. 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 United States, Puerto Rico. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Repeat STD infection (time frame: Average of 15-months post-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 NCT00164619, 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 Jun 2008.