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Completed

NCT Number: NCT01454921

Development of an Empowerment Intervention for Young Women Living With HIV

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.

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Key information

Conditions

HIV

Age range

16 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

USF College of Medicine, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

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

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Secondary Prevention Empowerment Intervention for Young Women Living With HIV

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2011
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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