Development of an Empowerment Intervention for Young Women Living With HIV

NCT01454921 | Completed Phase 2 DMC

• 1 other identifier: ATN 089
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV

Keywords

HIV; Adolescent Trials Network

Outcome Measures

Primary Outcomes (1)

• Compare pre-intervention, immediate post-intervention, and 3-month post-intervention scores on sexual risk and psychological empowerment

  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.

  1 year

Secondary Outcomes (1)

• 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

  1 year

Study Arms (2)

Intervention I

EXPERIMENTAL

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

Intervention II

EXPERIMENTAL

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

Interventions

Evolution: Young Women Taking Charge and Growing Stronger BEHAVIORAL

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).

Intervention I; Intervention II

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

USF College of Medicine

Tampa, Florida, 33606, United States

Location

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, 60612, United States

Location

University of Maryland Medical School

Baltimore, Maryland, 20723, United States

Location

Related Links

• ATN Website

Study Officials

• Gregory Zimet, PhD

  Adolescent Trials Network

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: October 19, 2011
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 28, 2017

Record last verified: 2016-03

Locations

US (3)