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Development of an Empowerment Intervention for Young Women Living With HIV

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ClinicalTrials.gov Identifier: NCT01454921
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 31, 2010
First Posted Date  ICMJE October 19, 2011
Last Update Posted Date February 28, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment [ Time Frame: 1 year ]
Compare pre-intervention ACASI scores on Sexual Activity and Sexual Risk and Psychological Empowerment Questionnaires with those collected immediately post-intervention and 3 months after intervention to determine effect of intervention on sexual risk and psychological empowerment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01454921 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on self-efficacy, sexual negotiation, relational violence, forgiveness, anger, substance use, life goals and outcomes, and affect regulation [ Time Frame: 1 year ]
Compare pre-intervention ACASI scores on three self-efficacy scales, two sexual negotiation scales, the Rosenberg Self-Esteem Scale, the CTS2, the HFS, the TAS, the ASSIST, a life goals/outcomes scale, and the Affect Regulation Scale with those collected immediately post-intervention and 3 months after intervention to determine effect of intervention on sexual risk and psychological empowerment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of an Empowerment Intervention for Young Women Living With HIV
Official Title  ICMJE A Secondary Prevention Empowerment Intervention for Young Women Living With HIV
Brief Summary

This study will develop/adapt a culturally appropriate secondary prevention intervention for young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation for a full-scale randomized trial.

Once the intervention is developed/adapted, the sites will pilot the interventions twice to enable modifications. 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 (STD). Data will be collected to assess the feasibility and acceptability of the newly developed intervention using both quantitative and qualitative methods at each iteration.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE Behavioral: Evolution: Young Women Taking Charge and Growing Stronger
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 (STD).
Study Arms  ICMJE
  • Experimental: Intervention I

    Intervention group participants will be enrolled for the duration of one intervention program, which will last approximately 6 months. Each intervention program will consist of two individual and six group intervention sessions with each session lasting approximately 2-3 hours.

    Intervention participants will also complete two ACASI assessments (baseline and post-intervention) lasting approximately 1.5-2 hours each.

    Intervention: Behavioral: Evolution: Young Women Taking Charge and Growing Stronger
  • Experimental: Intervention II

    Intervention group participants will be enrolled for the duration of one intervention program, which will last approximately 6 months. Each intervention program will consist of two individual and six group intervention sessions with each session lasting approximately 2-3 hours.

    Intervention participants will also complete two ACASI assessments (baseline and post-intervention) lasting approximately 1.5-2 hours each.

    Intervention: Behavioral: Evolution: Young Women Taking Charge and Growing Stronger
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2011)
43
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2011)
48
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 years (inclusive) at the time of informed consent/assent
  • Ability to understand both written and spoken English
  • Gives informed consent/assent for study participation

Exclusion Criteria:

  • Presence of active, serious psychiatric symptoms (e.g., hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements
  • Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
  • Intoxicated or under the influence of alcohol or other substances at the time of study enrollment*.

    • Intoxication at the time of visit will exclude participation at that time. Participants cannot be visibly under the influence of substances at the time of enrollment or consent. If a participant returns to enroll while sober, enrollment can occur. Similarly, if a participant arrives to an intervention group visibly intoxicated, then she will be asked to leave. However, prior intoxication does not eliminate future participation. Thus, those who are dismissed from a session due to intoxication can return to a subsequent session as long as they are sober.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01454921
Other Study ID Numbers  ICMJE ATN 089
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Study Chair: Gregory Zimet, PhD Adolescent Trials Network
PRS Account University of North Carolina, Chapel Hill
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP