Sexually Transmitted InfectionsE-WORTHNCT02391233
Multimedia WORTH With Black Drug-Involved Women on Probation
A study testing E-WORTH and Streamlined HIV Testing in people with Sexually Transmitted Infections and HIV, run by Columbia University at 1 site in United States.
Trial summary
The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections, HIV, Gonorrhea
- What is being tested?
- E-WORTH and Streamlined HIV Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2015to Sep 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- She is 18 or older.
- She is currently supervised by a criminal justice entity, such as a community court or probation.
- She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
- She reports any illicit drug use or binge drinking in the past 6 months
Who cannot join
- Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
- The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:
- Having sex with more than one partner
- Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
- Sharing injection drug use needles or equipment
- The woman is actively trying to get pregnant/have a baby.
- Inability to complete informed consent process due to a psychiatric or cognitive impairment.
- The participant was born male.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimedia HIV/STI Prevention for Black Drug-Involved Women on Probation
The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as Black) women drug users in probation sites in New York City (NYC), compared to streamlined HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. The primary outcomes will be to reduce cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex acts.
Read the detailed description
This randomized controlled trial will be conducted with 420 drug-involved Black women at 5 probation sites located in communities in NYC heavily affected by HIV and STIs. Eligible women will be randomly assigned to: (1) WORTH consisting of an individual evidence-based Streamlined HIV Testing session followed by a 4-session group-based multimedia HIV intervention (WORTH) or (2) an individual Streamlined HIV Testing session alone (Streamlined HIV Testing), which will serve as the comparison condition. Both conditions will be delivered by Fortune providers at the 5 sites. Self-reported data on behavioral outcomes will be collected from participants via audio computer-assisted self-interview (ACASI). Primary STI outcomes will be measured via biological assay for infection by Neisseria gonorrhea, trichomonas, and Chlamydia trachomatis, the most common STIs found among women in NYC. Women who meet eligibility criteria will undergo a pre-intervention assessment. This assessment will last approximately 60 minutes, consisting of demographic information, history of criminal justice involvement, drug and alcohol use and dependence, sexual and drug-related HIV behaviors, HIV treatment and care, intimate partner violence, depression and posttraumatic Stress Disorder (PTSD) , service utilization, and social support. Research assistants (RAs) will schedule repeated assessments with participants that will take place at baseline and at 3, 6, and 12 months post-intervention. Each participant will be asked to obtain one vaginal specimen for STI testing by inserting a sterile Dacron-tipped swab about 2.5 inches or as far as comfortable into the vagina, rotating it for 15 to 30 seconds, and removing it. The vaginal swabs are placed into separate specimen transport packaging.
- Conditions
- Sexually Transmitted Infections, HIV, Gonorrhea, Trichomonas, Chlamydia Trachomatis, Drug Use
- Being tested
- E-WORTH, Streamlined HIV Testing
- Keywords
- Effectiveness intervention, Cost-effectiveness intervention, HIV prevention, Sexually transmitted infections prevention, Multimedia evidence-based intervention, Drug-users, Black/African-American women, Probation, HIV testing
- Medical subject headings
- Sexually Transmitted Diseases, Gonorrhea, Trichomonas Infections, Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-WORTHBehavioural
E-WORTH (Empowering African-American Women on the Road to Health) consists of 1 Streamlined HIV Testing session followed by 5 one-and-a-half hour group sessions that will be delivered by a probation provider at the probation site. The main multimedia components used in the E-WORTH: (1) Narrativity; (2) Skill acquisition using simulated video vignettes that provides instruction and demonstration of core skills (e.g., safer sex negotiation and problem-solving skills, technical condom use skills) using culturally congruent role models; (3) Individual interactive exercises and logs that are designed to enhance participant's recall of core knowledge and tracking of their individual progress in reducing risky behaviors and achieving risk reduction goals; and a (4) Facilitator interactive guide.
Streamlined HIV TestingBehavioural
In this intervention Black Women on Probation receive streamlined HIV Testing alone to test primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation.
| Study group | Role | What they receive |
|---|---|---|
| HIV/STI Risk Reduction | Experimental | This intervention tests the comparative effectiveness of E-WORTH, streamlined HIV Testing and a 5-week multimedia intervention on primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation. Receives: Behavioral: E-WORTH; Behavioral: Streamlined HIV Testing |
| Streamlined HIV Testing Alone | Active comparator | This intervention tests the comparative effectiveness of streamlined HIV Testing alone on primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation. Receives: Behavioral: Streamlined HIV Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
Measured: Baseline and 12 months post-intervention
Change in the number of unprotected sex acts
Measured: Baseline and 12 months post-intervention
Secondary outcomes (6)
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas as moderated by participant race, age and other socio-demographics and psychosocial client characteristics
Measured: 12-months
Change in the number of unprotected sex acts as moderated by participant race, age and other socio-demographics and psychosocial client characteristics infection rates, drug use and projected number of HIV cases averted at the 12-month follow-up.
Measured: 12-month
Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
Measured: 12-month
Comparative change in the number of unprotected sex acts
Measured: 12-month
Change in cumulative incidence of biologically confirmed STIs as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society
Measured: 6-month
Change in the number of unprotected sex acts as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start15 Nov 2015
- Primary completionJun 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Fortune Society, University of Pennsylvania, State University of New York - Downstate Medical Center, RTI International, Duke University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Louisa Gilbert, Columbia University
- Investigators
- Louisa Gilbert, Ph.D., Principal investigator, Columbia UniversityNabila El-Bassel, Ph.D., Principal investigator, Columbia UniversityElwin Wu, Ph.D., Study director, Columbia UniversityTimothy Hunt, LCSW, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391233
- Sponsor's protocol ID
- AAAN8409
- Other IDs
- 1R01DA038122-01
- Acronym
- E-WORTH
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2015
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Goddard-Eckrich D, McCrimmon T, Bond K, Chang M, Hunt T, Hall J, Russo M, Ramesh V, Johnson KA, Downey DL, Wu E, El-Bassel N, Gilbert L. Effectiveness of a culturally tailored HIV intervention in promoting PrEP among black women who use drugs in community supervision programs in New York City: a randomized clinical trial. Addict Sci Clin Pract. 2024 Jul 23;19(1):55. doi: 10.1186/s13722-024-00488-0.
PubMed 39039560Gilbert L, Goddard-Eckrich D, Chang M, Hunt T, Wu E, Johnson K, Richards S, Goodwin S, Tibbetts R, Metsch LR, El-Bassel N. Effectiveness of a Culturally Tailored HIV and Sexually Transmitted Infection Prevention Intervention for Black Women in Community Supervision Programs: A Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e215226. doi: 10.1001/jamanetworkopen.2021.5226.
PubMed 33835175Johnson K, Gilbert L, Hunt T, Wu E, Metsch L, Goddard-Eckrich D, Richards S, Tibbetts R, Rowe JC, Wainberg ML, El-Bassel N. The effectiveness of a group-based computerized HIV/STI prevention intervention for black women who use drugs in the criminal justice system: study protocol for E-WORTH (Empowering African-American Women on the Road to Health), a Hybrid Type 1 randomized controlled trial. Trials. 2018 Sep 10;19(1):486. doi: 10.1186/s13063-018-2792-3.
PubMed 30201039
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia HIV/STI Prevention for Black Drug-Involved Women on Probation
- ClinicalTrials.gov ID
- NCT02391233
- Acronym / sponsor ID
- E-WORTH / AAAN8409
- Conditions
- Sexually Transmitted Infections, HIV, Gonorrhea, Trichomonas, Chlamydia Trachomatis, Drug Use
- Keywords
- Effectiveness intervention, Cost-effectiveness intervention, HIV prevention, Sexually transmitted infections prevention, Multimedia evidence-based intervention, Drug-users, Black/African-American women, Probation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Fortune Society, University of Pennsylvania, State University of New York - Downstate Medical Center, RTI International, Duke University, National Institute on Drug Abuse (NIDA)
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Mar 2015 (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 proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as Black) women drug users in probation sites in New York City (NYC), compared to streamlined HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. The primary outcomes will be to reduce cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex acts.
Detailed description
This randomized controlled trial will be conducted with 420 drug-involved Black women at 5 probation sites located in communities in NYC heavily affected by HIV and STIs. Eligible women will be randomly assigned to: (1) WORTH consisting of an individual evidence-based Streamlined HIV Testing session followed by a 4-session group-based multimedia HIV intervention (WORTH) or (2) an individual Streamlined HIV Testing session alone (Streamlined HIV Testing), which will serve as the comparison condition. Both conditions will be delivered by Fortune providers at the 5 sites. Self-reported data on behavioral outcomes will be collected from participants via audio computer-assisted self-interview (ACASI). Primary STI outcomes will be measured via biological assay for infection by Neisseria gonorrhea, trichomonas, and Chlamydia trachomatis, the most common STIs found among women in NYC. Women who meet eligibility criteria will undergo a pre-intervention assessment. This assessment will last approximately 60 minutes, consisting of demographic information, history of criminal justice involvement, drug and alcohol use and dependence, sexual and drug-related HIV behaviors, HIV treatment and care, intimate partner violence, depression and posttraumatic Stress Disorder (PTSD) , service utilization, and social support. Research assistants (RAs) will schedule repeated assessments with participants that will take place at baseline and at 3, 6, and 12 months post-intervention. Each participant will be asked to obtain one vaginal specimen for STI testing by inserting a sterile Dacron-tipped swab about 2.5 inches or as far as comfortable into the vagina, rotating it for 15 to 30 seconds, and removing it. The vaginal swabs are placed into separate specimen transport packaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV/STI Risk Reduction | Experimental | Behavioral: E-WORTH, Behavioral: Streamlined HIV TestingThis intervention tests the comparative effectiveness of E-WORTH, streamlined HIV Testing and a 5-week multimedia intervention on primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation. |
| Streamlined HIV Testing Alone | Active comparator | Behavioral: Streamlined HIV TestingThis intervention tests the comparative effectiveness of streamlined HIV Testing alone on primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- She is 18 or older.
- She is currently supervised by a criminal justice entity, such as a community court or probation.
- She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
- She reports any illicit drug use or binge drinking in the past 6 months
Key exclusion criteria (8 listed)
- Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
- The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:
- The woman is actively trying to get pregnant/have a baby.
- Inability to complete informed consent process due to a psychiatric or cognitive impairment.
- The participant was born male.
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 |
|---|---|---|
| E-WORTHE-WORTH (Empowering African-American Women on the Road to Health) consists of 1 Streamlined HIV Testing session followed by 5 one-and-a-half hour group sessions that will be delivered by a probation provider at the probation site. The main multimedia components used in the E-WORTH: (1) Narrativity; (2) Skill acquisition using simulated video vignettes that provides instruction and demonstration of core skills (e.g., safer sex negotiation and problem-solving skills, technical condom use skills) using culturally congruent role models; (3) Individual interactive exercises and logs that are designed to enhance participant's recall of core knowledge and tracking of their individual progress in reducing risky behaviors and achieving risk reduction goals; and a (4) Facilitator interactive guide. | Behavioural | HIV/STI Risk Reduction |
| Streamlined HIV TestingIn this intervention Black Women on Probation receive streamlined HIV Testing alone to test primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation. | Behavioural | HIV/STI Risk Reduction, Streamlined HIV Testing Alone |
Primary outcome
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
Time frame: Baseline and 12 months post-intervention
Change in the number of unprotected sex acts
Time frame: Baseline and 12 months post-intervention
6 secondary outcomes
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas as moderated by participant race, age and other socio-demographics and psychosocial client characteristics
Time frame: 12-months
Change in the number of unprotected sex acts as moderated by participant race, age and other socio-demographics and psychosocial client characteristics infection rates, drug use and projected number of HIV cases averted at the 12-month follow-up.
Time frame: 12-month
Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
Time frame: 12-month
Comparative change in the number of unprotected sex acts
Time frame: 12-month
Change in cumulative incidence of biologically confirmed STIs as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society
Time frame: 6-month
Change in the number of unprotected sex acts as moderated by sociodemographics and professional training, attitudes, and self-efficacy of probation officers, administrators, and probation providers from Fortune Society
Time frame: 6-month
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 27 Jul 2020.
- Derived from this study: PubMed 39039560Goddard-Eckrich D, McCrimmon T, Bond K, Chang M, Hunt T, Hall J, Russo M, Ramesh V, Johnson KA, Downey DL, Wu E, El-Bassel N, Gilbert L. Effectiveness of a culturally tailored HIV intervention in promoting PrEP among black women who use drugs in community supervision programs in New York City: a randomized clinical trial. Addict Sci Clin Pract. 2024 Jul 23;19(1):55. doi: 10.1186/s13722-024-00488-0.
- Derived from this study: PubMed 33835175Gilbert L, Goddard-Eckrich D, Chang M, Hunt T, Wu E, Johnson K, Richards S, Goodwin S, Tibbetts R, Metsch LR, El-Bassel N. Effectiveness of a Culturally Tailored HIV and Sexually Transmitted Infection Prevention Intervention for Black Women in Community Supervision Programs: A Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e215226. doi: 10.1001/jamanetworkopen.2021.5226.
- Derived from this study: PubMed 30201039Johnson K, Gilbert L, Hunt T, Wu E, Metsch L, Goddard-Eckrich D, Richards S, Tibbetts R, Rowe JC, Wainberg ML, El-Bassel N. The effectiveness of a group-based computerized HIV/STI prevention intervention for black women who use drugs in the criminal justice system: study protocol for E-WORTH (Empowering African-American Women on the Road to Health), a Hybrid Type 1 randomized controlled trial. Trials. 2018 Sep 10;19(1):486. doi: 10.1186/s13063-018-2792-3.
- Individual participant dataSharing planned: Undecided
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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.
Louisa Gilbert, Ph.D. principal investigator
Columbia University
Nabila El-Bassel, Ph.D. principal investigator
Columbia University
Elwin Wu, Ph.D. study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-WORTH and Streamlined HIV Testing in people with Sexually Transmitted Infections and HIV, run by Columbia University 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 4 inclusion and 8 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 27 Jul 2020. 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?
Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas. (time frame: Baseline and 12 months post-intervention). The study lists 2 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 NCT02391233, which also lists 3 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 27 Jul 2020.