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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137644
Other study ID # CDC-NCHSTP-CCU324516
Secondary ID U65/CCU324516
Status Completed
Phase Phase 1/Phase 2
First received August 26, 2005
Last updated January 6, 2010
Start date March 2005
Est. completion date January 2007

Study information

Verified date January 2010
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this program evaluation is to determine whether the Preventing AIDS Through Live Movement and Sound (PALMS) group-level intervention is effective in reducing HIV sex risk behaviors and increasing HIV testing of high-risk, incarcerated or adjudicated youth. The intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.


Description:

Philadelphia Health Management Corporation (PHMC) is evaluating the Preventing AIDS Through Live Movement and Sound (PALMS) group-level intervention for high-risk, incarcerated or adjudicated youth. PALMS uses three theater-based sessions to increase knowledge about HIV/AIDS, increase HIV testing, and reduce risky sexual behavior through increased self-efficacy. The intervention is delivered by peers, and peers work with the intervention team to use evaluation results to improve the program. The evaluation will recruit male adolescents, aged 12 to 18 years, who are residing in juvenile justice or drug treatment facilities in Philadelphia. The evaluation design uses concurrent intervention (N=132) and comparison (N=132) groups. Data will be collected at baseline, immediate post-intervention, and at a 6-month post-intervention follow-up. The intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Male adolescents

- Between the ages of 12 and 18

- Receiving residential services at juvenile justice or drug treatment facilities

- African-American or Latino

Exclusion Criteria:

- Do not speak English

- Prior participation in PALMS intervention

- Female adolescents

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Preventing AIDS Through Live Movement and Sound (PALMS)


Locations

Country Name City State
United States Philadelphia Health Management Corporation Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention Public Health Management Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual activity Within past 3 months & ever
Primary Number and type (main and non-main) of female sex partners Within past 3 months
Primary Frequency of condom use with female sex partners Within past 3 months
Primary HIV testing (ever tested, number of tests, likelihood of test) Within past 3 months
Secondary Drug use Within past 3 months
Secondary Knowledge of HIV transmission, prevention and testing Concurrent
Secondary Attitudes and beliefs about condoms and safe sex Concurrent
Secondary Beliefs about HIV and HIV testing Concurrent
Secondary Perception of HIV risk concurrent
Secondary Self-efficacy to use condoms and practice safe sex Concurrent
Secondary Self-esteem Concurrent
Secondary Perceptions of cultural and peer norms Concurrent
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