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HIVPhase 2Project WORTHNCT01784809

The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

A Phase 2 study testing Multimedia WORTH, Traditional WORTH and Wellness Promotion in people with HIV and Sexually Transmitted Infections, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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
HIV, Sexually Transmitted Infections
What is being tested?
Multimedia WORTH, Traditional WORTH and Wellness Promotion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
306 participants
Where
1 siteUnited States
Study dates
Nov 2009to Mar 2013
Phase
Phase 2
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.
  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University School of Social Work

    New York, New York, 10027

Other trials in United States

About this study

Official title: Multimedia HIV/STI Prevention for Drug-Involved Female Offenders

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.

Read the detailed 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.

Being tested
Multimedia WORTH, Traditional WORTH, Wellness Promotion
Keywords
HIV, STIs, Condom Use, Criminal Justice, Drug Use
Medical subject headings
Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimedia WORTHBehavioural

    The Multimedia WORTH intervention features the same core elements as the original version, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance group learning and individualized feedback. Participants will interact with Multimedia WORTH at two levels: (1) group materials will be delivered via computer projection onto a screen and (2) participants will complete individual activities and create journal logs tracking their progress on personalized goals on their personal user accounts using laptop computers. The computer multimedia support tool includes text, imagery, animations, audio and video in a format that guide the facilitator's delivery of the intervention. ***To view pilot features of the Multimedia WORTH intervention in development, please visit the following web address:

    http://ccnmtl.columbia.edu/projects/worth/presentation

  • Traditional WORTHBehavioural

    The basic format of each WORTH session remains consistent following a sequence of 5 steps: (1) an opening (quote, song, poem) which will provide a brief culturally relevant point of inspiration to engage participants (2) Check-in to review material from the previous session, and to discuss any incidents where participants engaged in risk behaviors and to acknowledge positive ways in which women used new skills to avoid HIV risk; (3) a discussion to raise awareness of links between IPV, drug-related activities, and HIV risks; (4) a skills-building component relevant to the discussion; and (5) review and update participant needs, homework assigned for skills-building at home, and a closing ritual. The WORTH intervention consists of four 2-hour group sessions that are led by a female facilitator.

  • Wellness PromotionBehavioural

Study groups in NCT01784809
Study groupRoleWhat they receive
Multimedia HIV/STI preventionExperimentalMultimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
Receives: Behavioral: Multimedia WORTH
Traditional HIV/STI preventionActive comparatorTraditional 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.
Receives: Behavioral: Traditional WORTH
Wellness PromotionPlacebo comparatorWellness 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.
Receives: Behavioral: Wellness Promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of condom protected acts of vaginal and anal intercourse

    Measured: Up to 12 months

Secondary outcomes (1)

  1. Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2013 (estimated)
  2. Study startNov 2009
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01784809
Sponsor's protocol ID
AAAD5608
Other IDs
R01DA025878
Acronym
Project WORTH
Status last verified
Feb 2014
First submitted
4 Feb 2013
Last updated
27 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Slavin MN, West BS, Schreiber-Gregory D, Levin FR, Wingood G, Martino S, Tzilos Wernette G, Black C, El-Bassel N. Correlates of Unmet Need for Modern Contraception Among Reproductive-Aged Women Involved in New York City Criminal Legal Systems. Womens Health Rep (New Rochelle). 2024 Feb 16;5(1):132-142. doi: 10.1089/whr.2023.0177. eCollection 2024.

    PubMed 38404679

  • Hochstatter KR, Slavin MN, Gilbert L, Goddard-Eckrich D, El-Bassel N. Availability of informal social support and the impact on health services utilization among women in community corrections who engage in substance use and risky sexual behavior: New York City, 2009-2012. Health Justice. 2022 Feb 16;10(1):6. doi: 10.1186/s40352-022-00170-0.

    PubMed 35171362

  • El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Hunt T, Epperson M, Shaw SA, Rowe J, Almonte M, Witte S. Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH. PLoS One. 2014 Nov 5;9(11):e111528. doi: 10.1371/journal.pone.0111528. eCollection 2014.

    PubMed 25372149

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Multimedia WORTH, Traditional WORTH and Wellness Promotion in people with HIV and Sexually Transmitted Infections, 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 13 inclusion and 0 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 Feb 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The proportion of condom protected acts of vaginal and anal intercourse (time frame: Up to 12 months). 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 NCT01784809, 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 Feb 2014.

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