NCT02391233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

November 15, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

March 12, 2015

Last Update Submit

July 24, 2020

Conditions

Sexually Transmitted InfectionsHIVGonorrheaTrichomonasChlamydia TrachomatisDrug Use

Keywords

Effectiveness interventionCost-effectiveness interventionHIV preventionSexually transmitted infections preventionMultimedia evidence-based interventionDrug-usersBlack/African-American womenProbationHIV testing

Outcome Measures

Primary Outcomes (2)

  • Change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.

    Baseline and 12 months post-intervention

  • Change in the number of unprotected sex acts

    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

    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.

    12-month

  • Comparative change in cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas.

    12-month

  • Comparative change in the number of unprotected sex acts

    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

    6-month

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: E-WORTHBehavioral: 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.

Behavioral: Streamlined HIV Testing

Interventions

E-WORTHBEHAVIORAL

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.

HIV/STI Risk Reduction
Streamlined HIV TestingBEHAVIORAL

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.

HIV/STI Risk ReductionStreamlined HIV Testing Alone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10027, United States

Location

Related Publications (3)

  • 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.

    PMID: 39039560DERIVED

  • 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.

    PMID: 33835175DERIVED

  • 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.

    PMID: 30201039DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesGonorrheaTrichomonas InfectionsDrug Misuse

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialProtozoan InfectionsParasitic DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Louisa Gilbert, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Nabila El-Bassel, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Elwin Wu, Ph.D.

    Columbia University

    STUDY DIRECTOR

  • Timothy Hunt, LCSW

    Columbia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Social Intervention Group, Columbia University School of Social Work, New York / Associate Professor, Columbia University School of Social Work, New York

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

November 15, 2015

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

US(1)