Condomless SexNCT02965014
NC Young Women's CoOp
A study testing Face-to-Face Young Women's CoOp (YWC), mHealth Young Women's CoOp (YWC) and HIV Counseling and Testing in people with Condomless Sex and Human Immunodeficiency Virus (HIV), run by RTI International at 4 sites in United States.
Trial summary
This three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI)
- What is being tested?
- Face-to-Face Young Women's CoOp (YWC), mHealth Young Women's CoOp (YWC) and HIV Counseling and Testing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jan 2017to 17 Mar 2020
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Participants may not be non-Black/African American
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Durham County Department of Public Health
Durham, North Carolina, 27701
Guilford County Department of Public Health - Greensboro
Greensboro, North Carolina, 27405
Guilford County Department of Public Health - High Point
High Point, North Carolina, 27260
Wake County Human Services
Raleigh, North Carolina, 27610
About this study
Official title: Young Women-Focused HIV Prevention: Seek & Test in North Carolina (NC) Clinics
This three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. The current study will develop a revised version of the YWC and evaluate the relative efficacy of a face-to-face (face-to-face YWC), mobile Health application (mHealth YWC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) African American women who use substances and are sexually active and have not recently been tested for HIV in three NC counties.
Read the detailed description
The purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused HIV risk-reduction intervention to reduce sexual risk among up to 700 young sexually active African American women aged 18 to 25 who use drugs in three North Carolina counties. The researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face YWC and mHealth YWC, using a three-arm cross-over randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face YWC; and (3) mHealth YWC that will be delivered on tablets using an interactive app. The researchers will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new YWC intervention and recruitment strategies using formative methods to engage young African American women who use substances and have not recently been tested for HIV, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mHealth YWC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face YWC and mHealth YWC) relative to HCT with up to 700 young women aged 18 to 25 in three North Carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (Aim 3) To estimate the total costs of implementing the face-to-face YWC and mHealth YWC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face YWC and mHealth YWC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.
- Conditions
- Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI), Alcohol and Drug Use
- Being tested
- Face-to-Face Young Women's CoOp (YWC), mHealth Young Women's CoOp (YWC), HIV Counseling and Testing
- Keywords
- Human Immunodeficiency Virus (HIV), Sexually transmitted infections (STI), mHealth, Substance abuse, Violence, Victimization, Sexual Risk
- Medical subject headings
- Unsafe Sex, Acquired Immunodeficiency Syndrome, 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.
Face-to-Face Young Women's CoOp (YWC)Behavioural
Participants will be offered HIV counseling and testing (HCT) and a two-session face-to-face YWC intervention. The face-to-face sessions will include information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal.
mHealth Young Women's CoOp (YWC)Behavioural
Participants will be offered HIV counseling and testing (HCT) and training on the mHealth application, which will include all content addressed in the face-to-face YWC delivery format. Participants will also be offered a tablet to complete the two-session intervention.
HIV Counseling and TestingBehavioural
Participants will be offered standard HIV counseling and testing (HCT).
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Young Women's CoOp (YWC) | Experimental | Participants in this arm will be offered a two-session face-to-face Young Women's CoOp (YWC) intervention. Receives: Behavioral: Face-to-Face Young Women's CoOp (YWC) |
| mHealth Young Women's CoOp (YWC) | Experimental | Participants in this arm will be offered training on the mobile health application mHealth Young Women's CoOp (YWC) and offered tablets with the mHealth application to complete the two-session intervention. Receives: Behavioral: mHealth Young Women's CoOp (YWC) |
| HIV Counseling and Testing | Active comparator | Participants will be offered standard HIV counseling and testing services. Receives: Behavioral: HIV Counseling and Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condomless Sex
Self-reported frequency of condomless sex
Measured: Baseline
Condomless Sex
Self-reported frequency of condomless sex
Measured: 6-month follow-up
Condomless Sex
Self-reported frequency of condomless sex
Measured: 12-month follow-up
Frequency of Substance Use
Frequency of using illicit drugs and alcohol
Measured: Baseline
Frequency of Substance Use
Frequency of using illicit drugs and alcohol
Measured: 6-month follow-up
Frequency of Substance Use
Frequency of using illicit drugs and alcohol
Measured: 12-month follow-up
Secondary outcomes (9)
Increased Sexual Negotiation
Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner
Measured: Baseline
Increased Sexual Negotiation
Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner
Measured: 6-month follow-up
Increased Sexual Negotiation
Self-reported ability to negotiate condom use and other safe sexual behavior with a male partner
Measured: 12-month follow-up
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
Self-reported amount of alcohol consumption and drugs used; Urine drug screen will be used to test for recent illicit drug use; Breathalyzer test results will be used to assess recent alcohol use
Measured: Baseline
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
Self-reported amount of alcohol consumption and drugs used; Urine drug screen will be used to test for recent illicit drug use; Breathalyzer test results will be used to assess recent alcohol use
Measured: 6-month follow-up
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
Self-reported amount of alcohol consumption and drugs used; Urine drug screen will be used to test for recent illicit drug use; Breathalyzer test results will be used to assess recent alcohol use
Measured: 12-month follow-up
Reduced Violence and Victimization for a Subsample of Participants
Self-reported experiences of emotional, physical, and sexual abuse
Measured: Baseline
Reduced Violence and Victimization for a Subsample of Participants
Self-reported experiences of emotional, physical, and sexual abuse
Measured: 6-month follow-up
Reduced Violence and Victimization for a Subsample of Participants
Self-reported experiences of emotional, physical, and sexual abuse
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start18 Jan 2017
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: Due to the COVID-19 pandemic, this health department-based trial ended early to limit utilizing clinic services and resources and to ensure participant and staff safety. This termination primarily affected the 12-month follow-up appointments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Condomless SexStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Durham County Department of Public Health, Guilford County Department of Public Health, Wake County Human Services
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965014
- Sponsor's protocol ID
- R01DA041009
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2016
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. Because there are fewer than 20,000 people in the data set, HIPAA says we cannot ensure that it is completely "de-identified"; consequently, HIPAA requires that we treat it as a "limited data set" and that we have a data sharing agreement (DSA) in place before giving anyone access to the client-level data. After the main findings are published, we will welcome other researchers who want to analyze the data in other ways. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and seeking the permission of the PI and her team.
Publications
Browne FA, Washio Y, Zule WA, Wechsberg WM. HIV-related risk among justice-involved young African American women in the U.S. South. Health Justice. 2023 Aug 24;11(1):32. doi: 10.1186/s40352-023-00228-7.
PubMed 37615878Osakwe CE, van der Drift I, Opper CA, Zule WA, Browne FA, Wechsberg WM. Condom Use at Last Sex and Sexual Negotiation Among Young African American Women in North Carolina: Context or Personal Agency. J Racial Ethn Health Disparities. 2024 Aug;11(4):2256-2264. doi: 10.1007/s40615-023-01693-4. Epub 2023 Jul 26.
PubMed 37495904Watkins RL, Browne FA, Kizakevich PN, Howard BN, Turner LB, Eckhoff R, Wechsberg WM. An Evidence-Based HIV Risk-Reduction Intervention for Young African American Women in the US South Using mHealth: Adaptation and Development Study. JMIR Form Res. 2022 May 9;6(5):e34041. doi: 10.2196/34041.
PubMed 35532978Opper CA, Browne FA, Howard BN, Zule WA, Wechsberg WM. Assessing Differences in mHealth Usability and App Experiences Among Young African American Women: Secondary Analysis of a Randomized Controlled Trial. JMIR Hum Factors. 2024 Apr 16;11:e51518. doi: 10.2196/51518.
PubMed 38625721Browne FA, Wechsberg WM, Kizakevich PN, Zule WA, Bonner CP, Madison AN, Howard BN, Turner LB. mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina. BMC Public Health. 2018 Aug 6;18(1):982. doi: 10.1186/s12889-018-5796-8.
PubMed 30081868
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
- Young Women-Focused HIV Prevention: Seek & Test in North Carolina (NC) Clinics
- ClinicalTrials.gov ID
- NCT02965014
- Acronym / sponsor ID
- R01DA041009
- Conditions
- Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI), Alcohol and Drug Use
- Keywords
- Human Immunodeficiency Virus (HIV), Sexually transmitted infections (STI), mHealth, Substance abuse, Violence, Victimization, Sexual Risk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 pandemic, this health department-based trial ended early to limit utilizing clinic services and resources and to ensure participant and staff safety. This termination primarily affected the 12-month follow-up appointments.
- Enrolment
- 652 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Durham County Department of Public Health, Guilford County Department of Public Health, Wake County Human Services
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 16 Nov 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 three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. The current study will develop a revised version of the YWC and evaluate the relative efficacy of a face-to-face (face-to-face YWC), mobile Health application (mHealth YWC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) African American women who use substances and are sexually active and have not recently been tested for HIV in three NC counties.
Detailed description
The purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused HIV risk-reduction intervention to reduce sexual risk among up to 700 young sexually active African American women aged 18 to 25 who use drugs in three North Carolina counties. The researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face YWC and mHealth YWC, using a three-arm cross-over randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face YWC; and (3) mHealth YWC that will be delivered on tablets using an interactive app. The researchers will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new YWC intervention and recruitment strategies using formative methods to engage young African American women who use substances and have not recently been tested for HIV, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mHealth YWC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face YWC and mHealth YWC) relative to HCT with up to 700 young women aged 18 to 25 in three North Carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (Aim 3) To estimate the total costs of implementing the face-to-face YWC and mHealth YWC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face YWC and mHealth YWC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Young Women's CoOp (YWC) | Experimental | Behavioral: Face-to-Face Young Women's CoOp (YWC)Participants in this arm will be offered a two-session face-to-face Young Women's CoOp (YWC) intervention. |
| mHealth Young Women's CoOp (YWC) | Experimental | Behavioral: mHealth Young Women's CoOp (YWC)Participants in this arm will be offered training on the mobile health application mHealth Young Women's CoOp (YWC) and offered tablets with the mHealth application to complete the two-session intervention. |
| HIV Counseling and Testing | Active comparator | Behavioral: HIV Counseling and TestingParticipants will be offered standard HIV counseling and testing services. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Participants may not be non-Black/African American
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 |
|---|---|---|
| Face-to-Face Young Women's CoOp (YWC)Participants will be offered HIV counseling and testing (HCT) and a two-session face-to-face YWC intervention. The face-to-face sessions will include information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. | Behavioural | Face-to-Face Young Women's CoOp (YWC) |
| mHealth Young Women's CoOp (YWC)Participants will be offered HIV counseling and testing (HCT) and training on the mHealth application, which will include all content addressed in the face-to-face YWC delivery format. Participants will also be offered a tablet to complete the two-session intervention. | Behavioural | mHealth Young Women's CoOp (YWC) |
| HIV Counseling and TestingParticipants will be offered standard HIV counseling and testing (HCT). | Behavioural | HIV Counseling and Testing |
Primary outcome
Condomless Sex
Time frame: Baseline
Self-reported frequency of condomless sex
Condomless Sex
Time frame: 6-month follow-up
Self-reported frequency of condomless sex
Condomless Sex
Time frame: 12-month follow-up
Self-reported frequency of condomless sex
Frequency of Substance Use
Time frame: Baseline
Frequency of using illicit drugs and alcohol
Frequency of Substance Use
Time frame: 6-month follow-up
Frequency of using illicit drugs and alcohol
Frequency of Substance Use
Time frame: 12-month follow-up
Frequency of using illicit drugs and alcohol
9 secondary outcomes
Increased Sexual Negotiation
Time frame: Baseline
Increased Sexual Negotiation
Time frame: 6-month follow-up
Increased Sexual Negotiation
Time frame: 12-month follow-up
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
Time frame: Baseline
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
Time frame: 6-month follow-up
Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
Time frame: 12-month follow-up
Reduced Violence and Victimization for a Subsample of Participants
Time frame: Baseline
Reduced Violence and Victimization for a Subsample of Participants
Time frame: 6-month follow-up
Reduced Violence and Victimization for a Subsample of Participants
Time frame: 12-month follow-up
Results and safety
The study was stopped early (reason given: Due to the COVID-19 pandemic, this health department-based trial ended early to limit utilizing clinic services and resources and to ensure participant and staff safety. This termination primarily affected the 12-month follow-up appointments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Results publication: PubMed 37615878Browne FA, Washio Y, Zule WA, Wechsberg WM. HIV-related risk among justice-involved young African American women in the U.S. South. Health Justice. 2023 Aug 24;11(1):32. doi: 10.1186/s40352-023-00228-7.
- Results publication: PubMed 37495904Osakwe CE, van der Drift I, Opper CA, Zule WA, Browne FA, Wechsberg WM. Condom Use at Last Sex and Sexual Negotiation Among Young African American Women in North Carolina: Context or Personal Agency. J Racial Ethn Health Disparities. 2024 Aug;11(4):2256-2264. doi: 10.1007/s40615-023-01693-4. Epub 2023 Jul 26.
- Results publication: PubMed 35532978Watkins RL, Browne FA, Kizakevich PN, Howard BN, Turner LB, Eckhoff R, Wechsberg WM. An Evidence-Based HIV Risk-Reduction Intervention for Young African American Women in the US South Using mHealth: Adaptation and Development Study. JMIR Form Res. 2022 May 9;6(5):e34041. doi: 10.2196/34041.
- Derived from this study: PubMed 38625721Opper CA, Browne FA, Howard BN, Zule WA, Wechsberg WM. Assessing Differences in mHealth Usability and App Experiences Among Young African American Women: Secondary Analysis of a Randomized Controlled Trial. JMIR Hum Factors. 2024 Apr 16;11:e51518. doi: 10.2196/51518.
- Derived from this study: PubMed 30081868Browne FA, Wechsberg WM, Kizakevich PN, Zule WA, Bonner CP, Madison AN, Howard BN, Turner LB. mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina. BMC Public Health. 2018 Aug 6;18(1):982. doi: 10.1186/s12889-018-5796-8.
- Individual participant dataSharing planned: Yes. 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. Because there are fewer than 20,000 people in the data set, HIPAA says we cannot ensure that it is completely "de-identified"; consequently, HIPAA requires that we treat it as a "limited data set" and that we have a data sharing agreement (DSA) in place before giving anyone access to the client-level data. After the main findings are published, we will welcome other researchers who want to analyze the data in other ways. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and seeking the permission of the PI and her team.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Young Women's CoOp (YWC), mHealth Young Women's CoOp (YWC) and HIV Counseling and Testing in people with Condomless Sex and Human Immunodeficiency Virus (HIV), run by RTI International at 4 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 0 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: stopped early, 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 4 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 was stopped early (reason given: Due to the COVID-19 pandemic, this health department-based trial ended early to limit utilizing clinic services and resources and to ensure participant and staff safety. This termination primarily affected the 12-month follow-up appointments.). Results are not available in the source record.
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?
Condomless Sex (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT02965014, which also lists 5 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.