HIVYWHCNCT02677025
Young Women's Health CoOp (Cooperative) in Cape Town
A study testing Young Women's Health CoOp (YWHC) and HIV Counseling/Testing in people with HIV and Substance Abuse, run by RTI International at 1 site in United States.
Trial summary
This supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. Read more about this study
- Who is it for?
- Ages 16 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Abuse
- What is being tested?
- Young Women's Health CoOp (YWHC) and HIV Counseling/Testing
- 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 siteUnited States
- Study dates
- May 2014to Apr 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 16 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female, 16 to 21 years of age
- Dropped out of school for at least 6 months
- Currently dropped out of school
- Have not completed matric or N 3 certificate
- Have used at least one drug (which can include alcohol) at least weekly in the past 90 days
- Report unprotected sex with a male partner in the last 90 days
- Able to provide informed assent to participate or informed consent if at least 18 years old
- Live in a targeted community Delft, Khayelitsha, or Mfuleni
Who cannot join
- Have been a part of formative activities
Trial locations and contacts
1 site in 1 country.
United States1 site
RTI International
Research Triangle Park, North Carolina, 27709
About this study
Official title: Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town
This supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female adolescents who experience the greatest burden of new HIV infections and are currently underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the validation of both the instrument and adapted intervention.
Read the detailed description
This study is testing and validating both the revised instrument and adapted intervention through a small pilot trial where a cluster randomized design is used to recruit 100 participants through snowball sampling by community to either the YWHC condition or standard HIV Counseling and Testing (HCT); collect biological specimens to screen for recent drug use, pregnancy and HIV infection and provide referrals for care to resources; conduct process evaluation measures for satisfaction and a 1-month follow-up post-intervention interview assessing the feasibility and preliminary efficacy of conducting this intervention among vulnerable young women and linking them to care.
Young women from disadvantaged communities in Cape Town who have dropped out of school and who use AODs are highly vulnerable to physical victimization (violence and sexual victimization) from any perpetrator, including main sexual partners and drug-related sexual risks for HIV. Yet these vulnerable young women remain underserved by current HIV and drug treatment programs in the region, even though they are experiencing the greatest burden of new HIV infections in the country. The adapted Young Women's Health CoOp (YWHC) intervention has a high likelihood of wider implementation, sustainability, and a significant public health impact by reducing the exceedingly high HIV incidence amongst the most vulnerable populations in South Africa.
- Conditions
- HIV, Substance Abuse
- Being tested
- Young Women's Health CoOp (YWHC), HIV Counseling/Testing
- Keywords
- HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization
- Medical subject headings
- Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Women's Health CoOp (YWHC)Behavioural
Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session.
HIV Counseling/TestingBehavioural
Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.
| Study group | Role | What they receive |
|---|---|---|
| Young Women's Health CoOp (YWHC) | Experimental | This is an adapted behavioral intervention for young women in Cape Town South Africa who dropped out of school, who use alcohol and other drugs and are at risk for HIV. Receives: Behavioral: Young Women's Health CoOp (YWHC) |
| HIV Counseling/Testing | Active comparator | Provide age and gender appropriate standard HIV counseling and testing. Receives: Behavioral: HIV Counseling/Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected intercourse among women
Percentages of condom use at last sex
Measured: One month post-intervention
Secondary outcomes (7)
Alcohol use
Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test
Measured: One month post-intervention
Alcohol use
Frequency of alcohol use in past 30 days measured by breath test
Measured: One month post-intervention
Substance use
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)
Measured: One month post-intervention
Substance use
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
Measured: One month post-intervention
Victimization
Percentages of young women who report being beaten in the previous 30 days
Measured: One month post-intervention
Victimization
Percentages of young women who report being attacked with a weapon in the previous 30 days
Measured: One month post-intervention
Victimization
Percentages of young women who report being forced to have sex in the previous 30 days
Measured: One month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionApr 2016
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 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677025
- Sponsor's protocol ID
- R01DA032061
- Acronym
- YWHC
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2016
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After the main findings are published, we welcome other researchers who want to analyze the data in other ways. Before this time, however, we anticipate establishing a publication plan that involves other researchers and institutions. Analytic data sets will be prepared in accordance with the "Privacy Rule" of the Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/) as "limited data sets" in which names and other personal health identifiers are removed, birthdays have been converted to age at intake, and other dates have been changed to be days before or after the date of intake.
Publications
Carney T, Browne FA, Myers B, Kline TL, Howard B, Wechsberg WM. Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town, South Africa. AIDS Care. 2019 Jan;31(1):77-84. doi: 10.1080/09540121.2018.1500008. Epub 2018 Jul 18.
PubMed 30021470
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
- Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town
- ClinicalTrials.gov ID
- NCT02677025
- Acronym / sponsor ID
- YWHC / R01DA032061
- Conditions
- HIV, Substance Abuse
- Keywords
- HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Feb 2016 (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 supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female adolescents who experience the greatest burden of new HIV infections and are currently underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the validation of both the instrument and adapted intervention.
Detailed description
This study is testing and validating both the revised instrument and adapted intervention through a small pilot trial where a cluster randomized design is used to recruit 100 participants through snowball sampling by community to either the YWHC condition or standard HIV Counseling and Testing (HCT); collect biological specimens to screen for recent drug use, pregnancy and HIV infection and provide referrals for care to resources; conduct process evaluation measures for satisfaction and a 1-month follow-up post-intervention interview assessing the feasibility and preliminary efficacy of conducting this intervention among vulnerable young women and linking them to care.
Young women from disadvantaged communities in Cape Town who have dropped out of school and who use AODs are highly vulnerable to physical victimization (violence and sexual victimization) from any perpetrator, including main sexual partners and drug-related sexual risks for HIV. Yet these vulnerable young women remain underserved by current HIV and drug treatment programs in the region, even though they are experiencing the greatest burden of new HIV infections in the country. The adapted Young Women's Health CoOp (YWHC) intervention has a high likelihood of wider implementation, sustainability, and a significant public health impact by reducing the exceedingly high HIV incidence amongst the most vulnerable populations in South Africa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Women's Health CoOp (YWHC) | Experimental | Behavioral: Young Women's Health CoOp (YWHC)This is an adapted behavioral intervention for young women in Cape Town South Africa who dropped out of school, who use alcohol and other drugs and are at risk for HIV. |
| HIV Counseling/Testing | Active comparator | Behavioral: HIV Counseling/TestingProvide age and gender appropriate standard HIV counseling and testing. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Female, 16 to 21 years of age
- Dropped out of school for at least 6 months
- Currently dropped out of school
- Have not completed matric or N 3 certificate
- Have used at least one drug (which can include alcohol) at least weekly in the past 90 days
Key exclusion criteria (1 listed)
- Have been a part of formative activities
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 Health CoOp (YWHC)Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session. | Behavioural | Young Women's Health CoOp (YWHC) |
| HIV Counseling/TestingParticipants will be tested for HIV and if positive will receive counseling in accordance with national standards. | Behavioural | HIV Counseling/Testing |
Primary outcome
Unprotected intercourse among women
Time frame: One month post-intervention
Percentages of condom use at last sex
7 secondary outcomes
Alcohol use
Time frame: One month post-intervention
Alcohol use
Time frame: One month post-intervention
Substance use
Time frame: One month post-intervention
Substance use
Time frame: One month post-intervention
Victimization
Time frame: One month post-intervention
Victimization
Time frame: One month post-intervention
Victimization
Time frame: One month 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.
- Derived from this study: PubMed 30021470Carney T, Browne FA, Myers B, Kline TL, Howard B, Wechsberg WM. Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town, South Africa. AIDS Care. 2019 Jan;31(1):77-84. doi: 10.1080/09540121.2018.1500008. Epub 2018 Jul 18.
- Individual participant dataSharing planned: Yes. After the main findings are published, we welcome other researchers who want to analyze the data in other ways. Before this time, however, we anticipate establishing a publication plan that involves other researchers and institutions. Analytic data sets will be prepared in accordance with the "Privacy Rule" of the Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/) as "limited data sets" in which names and other personal health identifiers are removed, birthdays have been converted to age at intake, and other dates have been changed to be days before or after the date of intake.
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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
1 site 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 Health CoOp (YWHC) and HIV Counseling/Testing in people with HIV and Substance Abuse, run by RTI International at 1 site 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 8 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 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 1 site 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?
Unprotected intercourse among women (time frame: One month 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 NCT02677025, 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 8 Jan 2025.