The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders (Project WORTH)

Columbia University

Status and phase: Completed; Phase 2

Conditions: Sexually Transmitted Infections; HIV

Treatments: Behavioral: Multimedia WORTH; Behavioral: Traditional WORTH; Behavioral: Wellness Promotion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01784809

AAAD5608

R01DA025878 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.

Full description

While it is clear that women inmates in jails and prisons bear a high burden of Human immunodeficiency virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), the effective development of prevention interventions for this high-risk group require an understanding of HIV risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system. HIV prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors. This study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.

Enrollment: 306 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:In addition, potential participants will be ineligible if any of the following criteria are met:

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 3 patient groups, including a placebo group

Multimedia HIV/STI prevention

Experimental group

Description:

Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.

Treatment:

Behavioral: Multimedia WORTH

Traditional HIV/STI prevention

Active Comparator group

Description:

Traditional WORTH is a 4-session group-based HIV/STI and drug abuse prevention intervention that covers the same content as Multimedia WORTH without the use of interactive videos, computerized assessments, and other audiovisual tools.

Treatment:

Behavioral: Traditional WORTH

Wellness Promotion

Placebo Comparator group

Description:

Wellness Promotion is a 4-session group based intervention that aims to improve diet, physical fitness and well-being which is designed as an attentional control condition.

Treatment:

Behavioral: Wellness Promotion