Multimedia WORTH With Black Drug-Involved Women on Probation

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.

Conditions

• Sexually Transmitted Infections
• HIV
• Gonorrhea
• Trichomonas
• Chlamydia Trachomatis
• Drug Use

Interventions

BEHAVIORAL

E-WORTH

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.

BEHAVIORAL

Streamlined HIV Testing

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.

Sponsors & Collaborators

• Fortune Society

  collaborator UNKNOWN

• University of Pennsylvania

  collaborator OTHER

• State University of New York - Downstate Medical Center

  collaborator OTHER

• RTI International

  collaborator OTHER

• Duke University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Louisa Gilbert, Ph.D. · Columbia University

• Nabila El-Bassel, Ph.D. · Columbia University

• Elwin Wu, Ph.D. · Columbia University

• Timothy Hunt, LCSW · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-11-15

Primary Completion

2019-06-30

Completion

2019-09-30

Countries

• United States

Study Locations