Clinical trial NCT02391233: Multimedia WORTH With Black Drug-Involved Women on Probation
Official title: Multimedia HIV/STI Prevention for Black Drug-Involved Women on Probation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
HIV testing
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Fortune Society
name: University of Pennsylvania
name: State University of New York - Downstate Medical Center
name: RTI International
name: Duke University
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-03-18
Enrollment: 354
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
timeFrame: Baseline and 12 months post-intervention
measure: Change in the number of unprotected sex acts
timeFrame: Baseline and 12 months post-intervention
Secondary outcomes:
measure: 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
timeFrame: 12-months
measure: 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.
timeFrame: 12-month
measure: Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.
timeFrame: 12-month
measure: Comparative change in the number of unprotected sex acts
timeFrame: 12-month
measure: 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
timeFrame: 6-month
measure: 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
timeFrame: 6-month
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Louisa Gilbert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Nabila El-Bassel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Elwin Wu, Ph.D.
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Timothy Hunt, LCSW
role: STUDY_DIRECTOR
References:
citation: Gilbert 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.
citation: Johnson 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.