CClinicalTrials.gg
CompletedNCT00891358Updated Mar 6, 2017

Empowerment Intervention for Young Women - Phase I

An interventional study of Prevention Empowerment Intervention for Young Women in HIV, Empowerment and HIV Infections, sponsored by University of North Carolina, Chapel Hill. Completed at 3 sites in United States. Open to female participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2017-03-06.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
16 Years to 24 Years
Sex
Female
01

Study summary

This study will begin to develop a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups.

Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An intervention will be developed/adapted through the data collected in the focus groups and review of relevant interventions. The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease.

Read the detailed description

This study will develop/adapt a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups. Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An initial list of content areas and potential activities for presentation to the focus groups will be developed by the protocol team by reviewing existing HIV prevention interventions that have been implemented with adolescents and young adults, as well as interventions that have targeted HIV+ populations.

Three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs. All focus groups will be digitally recorded and transcribed. Executive summaries of the groups will focus on the major themes elicited by probes that explore the proposed content and structure of the interventions. The summaries will be generated by members of the Protocol Team and based on a review and integration of data from a) focus group flip charts; b) digitally recorded comments from participants; c) digitally recorded oral summaries by moderators offered during the focus groups; and d) thematic notes taken by the assistant moderator during the focus groups. Based on the outcome of the focus groups, intervention modules will be developed and modified in collaboration with the Youth Advisory Team.

02

Conditions studied

  • HIV
  • Empowerment
  • HIV Infections

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Keywords

  • Adolescent Medicine Trials Network for HIV/AIDS Interventions
  • Human Immunodeficiency Virus
  • HIV seronegativity
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 17 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female at birth and currently female;
  • Receives services at one of the selected ATN sites or their community partners;
  • HIV-infected as documented by medical record review or verbal verification with referring professional;
  • Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
  • Ability to understand both written and spoken English; and
  • Gives informed consent/assent for study participation.

Exclusion criteria

Exclusion Criteria:

  • Presence of active, serious psychiatric symptoms (hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements;
  • Visibly distraught (suicidal, homicidal, exhibiting violent behavior);
  • If other serious conditions are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment; or
  • Intoxicated or under the influence of alcohol or other substances at the time of study enrollment*.

    • Participants cannot be visibly under the influence at the time of consent, enrollment, or during the focus group. Intoxication at the time of the focus group will exclude participation.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Focus Group

    Participants in focus groups will meet and discuss their intervention needs.

    Behavioral: Prevention Empowerment Intervention for Young Women

Interventions

  • BehavioralPrevention Empowerment Intervention for Young Women

    Using three intervention sites, focus groups will guide the development of the intervention's framework and content areas. An initial list of content areas and potential activities for presentation to the focus groups will be developed by the protocol team by reviewing existing HIV prevention interventions that have been implemented with adolescents and young adults, as well as interventions that have targeted HIV+ populations. The three focus groups will be convened (1 per selected ATN site) with young women living with HIV to solicit information on their intervention needs.

06

What researchers measure

Primary outcomes

  1. Use of focus groups for development/adaptation of a secondary prevention empowerment intervention to reduce sexual risk behavior among young women living with HIV.

    Time frame: 6-8 weeks

07

Study locations

3 sites
  • USF College of Medicine
    Tampa, Florida 33606, United States
  • Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
    Chicago, Illinois 60612, United States
  • University of Maryland Medical School
    Baltimore, Maryland 20723, United States
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References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00891358
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 1, 2009
Start date
Nov 2008
Primary completion
Jul 2009
Completion
Apr 2013
Last update
Mar 6, 2017

Study contacts

Sybil Hosek, PhD
study chair · John Stroger Hospital of Cook County; Adolescent Trials Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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