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Completed

NCT Number: NCT00161343

Maintaining HIV Prevention Gains in Female Adolescents

In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:

* randomized, controlled study * participants: 640 girls aged 15-19 years old * length of follow-up: 1 year after the intervention is completed

Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:

* lower incidence of STI's at 6 and 12 months, as compared to baseline * decreased incidence of risky sexual behaviors * increased knowledge of the level of risk of certain behaviors * increased knowledge of safer sexual behaviors that can prevention HIV infection * increased motivation to reduce sexual risk * increased behavioral skills to reduce risk of HIV infection

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester School of Nursing

Rochester, New York, 14642, United States

About this study

Adolescence is the only age category where the number of females infected with HIV outnumber the number of males. Despite these data, only three randomized controlled trials have evaluated the efficacy of a gender-specific HIV-risk reduction program for adolescent females. The proposed research aims to address this gap in HIV prevention science, and will evaluate the short and longer-term efficacy of a HIV-prevention intervention for adolescent girls. We will recruit 640 adolescent females aged 15 to 19 years from family planning clinics and randomly assign them to one of two conditions: (a) an HIV-risk reduction intervention based on the Information-Motivation-Behavioral Skills (IMB) model (Fisher & Fisher, 1992) or (b) a structurally equivalent health promotion control group (CTL) both supplemented by booster sessions at 3 and 6 months. At a short-term (3-month) follow-up, we hypothesize that IMB participants will increase HIV-related knowledge, motivation, and behavioral skills, and decrease the frequency of risky sexual practices relative to CTL participants. We will reassess all participants at 6 and 12 months to evaluate the longer-term efficacy of the interventions. At these longer-term follow-ups, we hypothesize that IMB participants will demonstrate higher levels of HIV knowledge, motivation, and behavioral skills; decreased risky sexual practices; and decreased rates of STDs (Chlamydia, gonorrhea) relative to the CTL participants. The final aim of the proposed research is to determine whether the constructs in the Information-Motivation-Behavioral Skills (IMB) Model (Fisher & Fisher, 1992), can account for variability in HIV-related behavior. We hypothesize that preventive behavior at 6 and 12 months will be a function of a participant's HIV-related information, motivation, and behavioral skills at the 3-month follow-up, and that information and motivation will be partially mediated by behavioral skills to influence the initiation and maintenance of HIV preventive behavior. The long-term intent of the proposed research is to develop a risk reduction program that can be used by community-based health organizations to reduce the risk of HIV infection among adolescent females.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 15-19 years old
  • Sexually active in the past 3 months
  • Available for follow-up contacts over the next 13 months
  • English speaking

Exclusion criteria

  • Pregnant, or had a baby in the last 3 months
  • Married or living with a partner

Treatment and study plan

Health Improvement Project for Teens on HIV Prevention

Behavioral

Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls

Other names: HIP Teens

Primary outcomes

  1. rates of STIs

    Time frame: Baseline, 6 and 12 months

  2. computer-assisted survey results

    Time frame: baseline, 1 week, 3, 6, & 12 months

  3. - score on self-report of frequency of risky sexual and substance use behaviors

    Time frame: baseline, 1 week, 3, 6, & 12 months

Secondary outcomes

  1. - score on assessments of information, motivation, and behavioral skills to reduce risk for HIV

    Time frame: baseline, 3, 6, & 12 months

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
Sep 6, 2012

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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