Viewing Study NCT00362375



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Study NCT ID: NCT00362375
Status: COMPLETED
Last Update Posted: 2010-05-14
First Post: 2006-08-08

Brief Title: Evaluation of the Healthy Love Workshop an HIV Prevention Intervention for African American Women
Sponsor: Centers for Disease Control and Prevention
Organization: Centers for Disease Control and Prevention

Study Overview

Official Title: Evaluation of the Healthy Love Workshop an HIV Prevention Intervention for African American Women by SisterLove Inc in Atlanta GA
Status: COMPLETED
Status Verified Date: 2010-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this program evaluation is to determine whether the Health Love Workshop a group-level HIV behavioral intervention reduces HIV-related sex risk behaviors and increases HIV protective behaviors of African American women and women of African descent The intent of this program is to support an evaluation of the efficacy of the intervention and to provide feedback to the implementing organization to increase intervention effectiveness
Detailed Description: SisterLove Inc in Atlanta Georgia is evaluating its HIVAIDS prevention intervention called the Healthy Love Workshop HLW The HLW targets African American women and women of African descent who are at risk for HIV infection and transmission The HLW which lasts 3 to 4 hours and is delivered during a single session is a highly interactive workshop that aims to provide a safe environment in which women can learn about a the modes of HIV transmission b effective strategies for reducing ones risk for contracting or transmitting HIV or other STIs c opportunities to develop or enhance skills for self-assessing the risk level of sexual behaviors and the use of safer sex techniques and d how to develop an awareness of personal community and social attitudes beliefs and norms that influence womens relationships sexual behavior and decision-making SisterLove will identify a minimum of 28 groups of women to participate in the evaluation which will use a concurrent comparison design with block randomization These groups will be typical of those that currently receive the HLW including but not limited to sororities friendship circles church groups and other affinity-based groups Fourteen of the 28 groups will participate in HLW as the intervention group 14 of the recruited groups will participate in an HIVAIDS 101 workshop HIV 101 as the comparison group Each group will contain about 15 women thus approximately 420 women will participate in the evaluation Outcome measures will assess HIVAIDS knowledge attitudes towards condom use and HIV testing condom use intentions personal HIVAIDS risk assessment self-efficacy for taking steps to prevent HIV transmission consistent condom use sexual abstinence and reduction in other sexual risk behaviors These outcomes will be measured at baseline and after the intervention at 3- and 6-month follow-ups

Eligible groups of women were randomly assigned to receive the intervention 15 groups 161 women or a comparison workshop 15 groups 152 women Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups Among sexually active women at the 3-month follow-up HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner and to have used condoms at last vaginal anal or oral sex with any male partner At the 6-month follow-up HLW participants were more likely to report condom use at last vaginal anal or oral sex with any male partner and having an HIV test and receiving their test results The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention This study also demonstrates that a CBO can develop and deliver a culturally appropriate effective HIV prevention intervention for the population it serves and with adequate resources and technical assistance rigorously evaluate its intervention

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U65CCU424514-02 OTHER_GRANT CDC Cooperative Agreement U65CCU424514 None