HIVYWCNCT01224184
Young Women's CoOp Study
A study testing Young Women's CoOp and Staying Healthy and Eating Well in people with HIV and Sexual Risk, run by RTI International at 2 sites in United States.
Trial summary
The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among African-American young women relative to general health intervention. Read more about this study
- Who is it for?
- Ages 16 to 19 years, women only
- Conditions the study is for
- HIV, Sexual Risk, Sexually Transmitted Diseases
- What is being tested?
- Young Women's CoOp and Staying Healthy and Eating Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Sep 2013
- 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 16 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Black/African-American
- 16-19 years of age
- Have dropped out of school at least once or are having problems that they have considered dropping out of school, and have not yet completed high school or GED program
- Have not graduated from a high school or alternative school, or completed a General Education Development (GED) program
- Have had vaginal sex at least once in the past 90 days with a male partner
Show all 9Show fewer
- Have used one of the following at least once in the past 90 days--alcohol, marijuana, cocaine/crack, heroin, ecstasy, methamphetamine, any prescription drugs not prescribed to them, or any other illicit substance.
- Will be in the area for the next 8 months
- Has not participated in previous formative activities of the study (e.g., interviews, focus groups, pretesting and pilot testing),
Who cannot join
- Not interested in coming to a health behavior study
- Not able to attend 4 sessions and 2 follow ups
Trial locations and contacts
2 sites in 1 country.
United States2 sites
RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham
Durham, North Carolina, 27703
RTI International - Headquarters
Research Triangle Park, North Carolina, 27709
About this study
Official title: Adapting the Women's CoOp for At-Risk Teens
The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among African-American young women relative to general health intervention.
Read the detailed description
This study completed an extensive formative phase to adapt the Women's CoOp intervention to specifically address the needs of young out-of-school adolescent African-American females with regard to knowledge about sexually transmitted infections (STIs), HIV and sexuality, health consequences of substance abuse, relationships with males, condom communication and social support, and HIV risk-reduction and violence prevention methods. During this phase, in-depth interviews, focus groups, pretesting and pilot testing were conducted to adapt and refine the intervention for the clinical trial.
The aim of this trial is to:
- Evaluate the efficacy of the cultural-, age-, and gender-focused intervention (Young Women's CoOp) relative to an equal attention control nutrition intervention in terms of changes in behaviors (e.g., condom use, substance use, violence prevention).
At study enrollment/baseline, participants completed a questionnaire and baseline drug and pregnancy testing, and were randomized into one of two programs: Young Women's CoOp or Staying Healthy and Eating Well (Nutrition)-both which included 3 individual intervention sessions and 1 group activity. Follow-ups were conducted 3-months post-intervention and 6-months post-intervention and included a questionnaire and drug testing.
The study has since been completed and analysis and manuscript preparation is underway. Two abstracts have been accepted to American Public Health Association conferences in 2012 and 2013. The five papers in progress or published include:
- Efficacy of the Young Women's Coop - analysis complete, manuscript being drafted
- Summary of qualitative findings from interviews and focus groups - published September 2013
- Homelessness and abuse- in final preparation
- Correlates of gang affiliation - manuscript complete, CDC clearance obtained, under review.
- Post intervention social determinants - re-analyses and re-write
- Conditions
- HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization
- Being tested
- Young Women's CoOp, Staying Healthy and Eating Well
- Keywords
- HIV, Sexually Transmitted Diseases, Substance Abuse Detection, Randomized Controlled Trial
- Medical subject headings
- Sexually Transmitted Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Women's CoOpBehavioural
Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).
Staying Healthy and Eating WellBehavioural
Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition | Active comparator | Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness. Receives: Behavioral: Staying Healthy and Eating Well |
| Young Women's | Experimental | Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (Principal Investigator (PI): Dr. Wendee M. Wechsberg). Receives: Behavioral: Young Women's CoOp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in behaviors, including condom use, substance use and violence prevention
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 posted19 Oct 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2013
- Study completionSep 2013
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224184
- Sponsor's protocol ID
- 5UR6PS000665-04
- Acronym
- YWC
- Status last verified
- Jan 2025
- First submitted
- 13 Oct 2010
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. No abstract available.
PubMed 21473554Browne, F. A., Wechsberg, W. M., White, V. L., Middlesteadt Ellerson, R., Raiford, R. L., Carry, M. G., Herbst, J.H. (in press).
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the Women's CoOp for At-Risk Teens
- ClinicalTrials.gov ID
- NCT01224184
- Acronym / sponsor ID
- YWC / 5UR6PS000665-04
- Conditions
- HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization
- Keywords
- HIV, Sexually Transmitted Diseases, Substance Abuse Detection, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Oct 2010 (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 this study is to test the efficacy of a cultural-, age- and gender-focused Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among African-American young women relative to general health intervention.
Detailed description
This study completed an extensive formative phase to adapt the Women's CoOp intervention to specifically address the needs of young out-of-school adolescent African-American females with regard to knowledge about sexually transmitted infections (STIs), HIV and sexuality, health consequences of substance abuse, relationships with males, condom communication and social support, and HIV risk-reduction and violence prevention methods. During this phase, in-depth interviews, focus groups, pretesting and pilot testing were conducted to adapt and refine the intervention for the clinical trial.
The aim of this trial is to:
- Evaluate the efficacy of the cultural-, age-, and gender-focused intervention (Young Women's CoOp) relative to an equal attention control nutrition intervention in terms of changes in behaviors (e.g., condom use, substance use, violence prevention).
At study enrollment/baseline, participants completed a questionnaire and baseline drug and pregnancy testing, and were randomized into one of two programs: Young Women's CoOp or Staying Healthy and Eating Well (Nutrition)-both which included 3 individual intervention sessions and 1 group activity. Follow-ups were conducted 3-months post-intervention and 6-months post-intervention and included a questionnaire and drug testing.
The study has since been completed and analysis and manuscript preparation is underway. Two abstracts have been accepted to American Public Health Association conferences in 2012 and 2013. The five papers in progress or published include:
- Efficacy of the Young Women's Coop - analysis complete, manuscript being drafted
- Summary of qualitative findings from interviews and focus groups - published September 2013
- Homelessness and abuse- in final preparation
- Correlates of gang affiliation - manuscript complete, CDC clearance obtained, under review.
- Post intervention social determinants - re-analyses and re-write
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Active comparator | Behavioral: Staying Healthy and Eating WellParticipants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness. |
| Young Women's | Experimental | Behavioral: Young Women's CoOpParticipants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (Principal Investigator (PI): Dr. Wendee M. Wechsberg). |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Female
- Black/African-American
- 16-19 years of age
- Have dropped out of school at least once or are having problems that they have considered dropping out of school, and have not yet completed high school or GED program
- Have not graduated from a high school or alternative school, or completed a General Education Development (GED) program
Key exclusion criteria (2 listed)
- Not interested in coming to a health behavior study
- Not able to attend 4 sessions and 2 follow ups
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 |
|---|---|---|
| Young Women's CoOpParticipants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg). | Behavioural | Young Women's |
| Staying Healthy and Eating WellParticipants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness. | Behavioural | Nutrition |
Primary outcome
Changes in behaviors, including condom use, substance use and violence prevention
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 8 Jan 2025.
- Background: PubMed 21473554Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. No abstract available.
- BackgroundBrowne, F. A., Wechsberg, W. M., White, V. L., Middlesteadt Ellerson, R., Raiford, R. L., Carry, M. G., Herbst, J.H. (in press).
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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.
Felicia Browne, ScD principal investigator
RTI International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young Women's CoOp and Staying Healthy and Eating Well in people with HIV and Sexual Risk, run by RTI International at 2 sites in United States.
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 9 inclusion and 2 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 8 Jan 2025. 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. 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?
Changes in behaviors, including condom use, substance use and violence prevention (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?
On the ClinicalTrials.gov record for NCT01224184, 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 8 Jan 2025.