Development of an Empowerment Intervention for Young Women Living With HIV

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01454921
First received: August 31, 2010
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV
Behavioral: Evolution: Young Women Taking Charge and Growing Stronger
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Secondary Prevention Empowerment Intervention for Young Women Living With HIV

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
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.

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).

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454921

Locations
United States, Florida
USF College of Medicine
Tampa, Florida, United States, 33606
United States, Illinois
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland Medical School
Baltimore, Maryland, United States, 20723
Sponsors and Collaborators
Investigators
Study Chair: Gregory Zimet, PhD Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01454921     History of Changes
Other Study ID Numbers: ATN 089
Study First Received: August 31, 2010
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV
Adolescent Trials Network

ClinicalTrials.gov processed this record on October 16, 2014